An Adjusted Preventive Program Against Lifestyle Related Diseases (TOFpilot2)
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|ClinicalTrials.gov Identifier: NCT03913585|
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 16, 2019
|First Submitted Date ICMJE||October 5, 2018|
|First Posted Date ICMJE||April 12, 2019|
|Last Update Posted Date||April 16, 2019|
|Actual Study Start Date ICMJE||October 22, 2018|
|Estimated Primary Completion Date||May 31, 2020 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT03913585 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||An Adjusted Preventive Program Against Lifestyle Related Diseases|
|Official Title ICMJE||Early Detection and Prevention of Lifestyle Related Diseases - Pilot2|
A large proportion of the Danish population leads an unhealthy lifestyle. The associated surge in lifestyle-related disease (LRD) represents a significant health and economic burden for the individual as well as society. However, the reactive nature of the Danish national health-care system, complicates a comprehensive and concerted preventive response to this issue. The TOF project aims to remedy this situation by 1) Using digital support systems to systematically identify citizens at risk of LRD and 2) Target the preventive services at citizens with the highest need. Specifically, the ultimate goal of TOF is to integrate the clinical and municipal preventive primary health-care system into a targeted preventive service that facilitates lifestyle change in the at-risk population, and thus reduces LRD at a population level. To this end, we have developed a complex intervention in close collaboration with central stakeholders (health professionals, citizens). The initial feasibility of the intervention has been tested in a pilot study comprising two municipalities, 47 GPs, and 8814 citizens. The intervention has subsequently been adjusted in collaboration with the end users, focusing both on recruitment activities and implementation activities in general practice. The upcoming step involves testing of the adjusted intervention (Pilot2), before large-scale implementation and efficacy evaluation.
The feasibility, acceptability, and short-term effect of the adjusted intervention will be tested in two municipalities using quantitative as well as qualitative research methods. The evaluation will focus on the reach of the intervention, the implementation and acceptability of the intervention in general practice and municipality, the use and assessment of the digital support system and the possible short-term effects on patient lifestyle and risk of disease. We expect 15 general practitioners and 4800 patients to participate.
The intervention comprises four main components:
Two (Haderslev and Middelfart) of the seven municipalities participating in the large-scale TOF study volunteered to participate in Pilot2. In February-March 2018, GPs from these two municipalities will receive an invitation to participate. The target group of Pilot2 comprises 4.800 adults born between 1959 and 1988 and who are registered with a participating GP.
Prior to study commencement, all enrolled GPs, practice nurses (PN), and health professionals from the municipalities are invited to a joint kick-off meeting. The meeting will focus on the intervention activities and tasks assigned to the GP clinics and the municipality. In addition, all GP practices will be offered an introductory visit from the project secretariat to help organize and plan project activities.
In October 2018 half of the target population will receive a mailed pre-notification (postcard), and 2 weeks later the full target population will receive an invitation, sent on behalf of the GP and the municipality to the individual's e-Boks. Two different invitations are tested; a) A broad invitation and b) an invitation targeting citizens with low educational attainment. Random selection is used to allocate citizens to the four invitation groups: (+/- postcard x Invitation a/b). To enroll in the study, citizens are asked to sign a consent form via a link to a secure, digital support system, accessible only with a two-phased NemID password. The consent form will outline study participation and disclosure of data from the GPs electronic patient record (EPR). Short videos on the digital support system will also be made available to participants. These videos come in different versions, designed for male and female participants, specifically. The main purpose of including the videos is to describe the purpose of the study and the intervention. To adjust for social inequality in health, proactive recruitment activities will be conducted by the participating municipalities in socially deprived areas.
Upon consent, information on relevant diagnoses (International Classification of Primary Care (ICPC-2) codes) and prescribed medicine (Anatomical Therapeutic Chemical Classification (ATC) codes incl. text fields with indication for treatment) are collected from the GPs' EPR systems.
Five months after consent (April 2019), participants will receive another digital invitation in their e-Boks, this time to fill in a questionnaire and access their personal health profile. Participants can opt out at any time during the intervention period by clicking an "opt-out" button on the digital support system.
Intervention The intervention comprises a two-pronged approach: (1) A joint intervention that applies to the entire sample, regardless of whether the participants are healthy, at risk, or already in treatment for type 2 diabetes (T2DM), chronic obstructive pulmonary disease (COPD), cardio vascular disease (CVD), hypercholesterolemia or hypertension; (2) A targeted intervention that is offered only to participants who presumably would benefit from either further examinations at the GP (high risk), or community health services, such as smoking cessation, dietary advice, or physical activity (health-risk behavior).
The joint intervention consists of:
The targeted intervention consists of:
For all present intents and purposes, the term health dialogue refers to a consultation that includes the elements of the 5As model and the techniques used in motivational interviewing.
The joint intervention All participants will have access to the digital support system, and are invited to fill in a questionnaire, comprising 15 items on height, weight, self-perceived health status, family history of LRD, COPD-related symptoms, smoking status, leisure activity level, alcohol consumption, diet, and osteoarthritis risk factors. Questions about family history of diabetes and leisure activity level were taken from the Danish Diabetes Risk model. Similarly, questions on COPD-related symptoms and smoking status were derived from the COPD-PS screener and the Heartscore BMI score. Items tapping dietary habits were from the Swedish National Guidelines on Disease Prevention. The questionnaire takes approximately five minutes to complete.
Based on the questionnaire and information from the individual EPR, participants are stratified into four distinct risk groups:
Personal health profile Based on results of the stratification process, each patient receives a personal health profile on the digital support system. The purpose of the health profile is to encourage the patients to change their health-risk behavior and follow the tailored advice provided by the system. Patients who are at increased risk of developing an LRD (Group 2) are advised to consult their GP for further examination and advice. Similarly, patients engaging in health-risk behavior (Group 3) are offered lifestyle counseling, or lifestyle courses in the municipality. By definition, Group 4 patients lead a relatively healthy life with no need for health-risk behavior change. Group 1 patients are advised to continue their treatment and use the information provided to change health-risk behavior.
The personal health profile includes individualized information on current health-risk behavior and risk of disease. The information is tailored based on the questionnaire, the information from the EPR, and the risk scores on COPD, T2DM, and CVD. It also includes general health information and information about preventive health services concerning smoking, diet, exercise, and alcohol consumption. This information is provided by the municipality, the Region of Southern Denmark, or the national health services, and targets the individual (e.g. via links to apps and webpages) based on his/her specific health-risk behavior.
The targeted intervention The intervention at the GP The intervention at the general practice level consists of a focused clinical examination and a subsequent health dialogue and is offered to patients who are at increased risk of developing an LRD (Group 2). Group 2 patients accept the offer of the intervention by scheduling an appointment at the GP (either by phone or the GP's webpage). Group 2 patients also have the opportunity to register for a telephone call from their GP on the digital support system. Whether the patient participates in the intervention or not is thus determined by their motivation and capabilities as well as the extent to which the content of the personal health profile motivates the patient to take action. The intervention is applied within the framework of the 5As model. The focused clinical examination includes measurements of blood glucose (HbA1c) and cholesterol levels, as well as height, weight, blood pressure, and lung function measurements, and an electrocardiogram (ECG), depending on the patient's health profile. Results from the examinations are registered in the digital support system where both the patient and the GP can access them at any time. Based on results from the health examination the GP may decide to offer the patient a health dialogue in general practice or the intervention in the in the municipality (described below). Patients offered a health dialogue in general practice are given the opportunity to prepare for the subsequent health dialogue by answering a questionnaire inspired by three systematic reviews on the determinants of behavior change. These include questions about motivation, resources, former experiences with behavior change, social network, mental health (WHO-5 for stress; Major Depression Inventory (MDI) for depression, and an open field section to qualitatively report on perceived facilitators and barriers to behavior change (a so-called balance-sheet). The questionnaire results are shared with the GP on the digital support system. Based on the health dialogue, the GP and the patient develop a prevention plan that includes a goal, a time frame, and identification of the appropriate means to fulfill the plan (e.g. reference to a smoking cessation course, or follow-up at the GP). The prevention plan is uploaded to the digital support system by the GP, and henceforth is accessible to both the GP and the patient.
The intervention at the municipal level The intervention at the municipal level is offered to patients exhibiting health-risk behavior (Group 3), and Group 2 patients referred to the municipality by the GP. The intervention consists of a short telephone consultation with a health professional - for example a nurse, a dietician, or a physiotherapist. A subsequent face-to-face health dialogue is offered to patients who may benefit from more extensive support. Patients request the telephone consultation on the digital support system by filling in a short form and sending it by e-mail to the municipality. A municipal health professional will then call the patient within the following week. Similar to the GP intervention, the intervention at the municipal level is thus also determined by patient motivation and capabilities as well as the extent to which the content of the personal health profile motivates the patient to take action. Immediately after the intervention, a participation form is sent to the municipality. Patients can prepare for the upcoming call from a municipal health professional in the same way as Group 2 patients prepare for the health dialogue - that is, by answering a short questionnaire. Ultimately, a prevention plan, including concrete details on its execution, is developed based on the telephone consultation and the face-to-face health dialogue. The prevention plan is registered by the municipal health professional and presented on the digital support system to both the municipality and the patient.
The entire intervention will be offered to the participants during a four-month period from April to July 2019.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Intervention Model: Single Group Assignment
Intervention Model Description:
To test the acceptability, feasibility and short-term effect of a selective preventive program that systematically helps citizens evaluate individual risk of lifestyle related disease and, if needed, offers targeted and coordinated preventive services in the primary health care sector.Masking: None (Open Label)
Primary Purpose: Health Services Research
|Condition ICMJE||Lifestyle-Related Disorder|
|Intervention ICMJE||Behavioral: Lifestyle intervention
Upon inclusion and consent all patients receive a questionnaire to estimate risk of disease and risk behavior. Information about lifestyle is systematically registered and collated with existing Electronic Patient Record (EPR) data and the patients risk of developing a lifestyle-related disease is estimated based on validated algorithms for risk of type-2 diabetes, cardiovascular disease and COPD (Stratification). All patients receive digital feedback including a personal health profile and targeted advice. Patients at high risk of lifestyle-related disease(s) are offered targeted prevention activities at the GP including a health examination and if needed a health dialog. Patients with health risk behavior are offered behavior counselling in the municipality and community health services, if necessary. Patients diagnosed with a lifestyle related disease and patients with a healthy lifestyle are not offered any further services.
Other Name: TOF project
|Study Arms ICMJE||Experimental: Lifestyle intervention
The intervention group comprises ~4800 patients born 1959-1988, living in the municipalities of Haderslev or Middelfart, and affiliated to one of the participating GPs. No control group is included.
Intervention: Behavioral: Lifestyle intervention
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||August 31, 2020|
|Estimated Primary Completion Date||May 31, 2020 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||29 Years to 59 Years (Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Listed Location Countries ICMJE||Denmark|
|Removed Location Countries|
|NCT Number ICMJE||NCT03913585|
|Other Study ID Numbers ICMJE||TOFpilot2
18/32742 ( Registry Identifier: Research & Innovation Organisation, University of Southern Denmark )
ID: 125508 ( Other Grant/Funding Number: Trygfonden )
18/5270 ( Other Grant/Funding Number: The Committee of Quality and Education in General Practice, The Region of Southern Denmark )
11/13244 ( Other Grant/Funding Number: Region of Southern Denmark )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||University of Southern Denmark|
|Study Sponsor ICMJE||University of Southern Denmark|
|Collaborators ICMJE||University of Oslo|
|PRS Account||University of Southern Denmark|
|Verification Date||April 2019|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP